Regulatory Affairs Analyst, Operations - Hidalgo, México - Colgate-Palmolive

Colgate-Palmolive

Empresa verificada

Hidalgo, México

hace 1 semana

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

No Relocation Assistance Offered
Del.
Miguel Hidalgo, Mexico City, Mexico

This position will help to maintain product compliance during the whole life-cycle, for any category of products, for Mexico territory, as well as to deliver core dossier for LATAM, mainly for Cosmetics, Household Products and Medical Device.

Key Responsibilities:

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Report regularly the progress to Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
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Assist the Regional Regulatory Affairs Department in preparing submissions to Competent Authorities and Notified Bodies, ensuring timely approval of new products and life-cycle submissions.
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Keep track of outstanding documentation and notify the relevant Regional Regulatory Affairs manager on a timely manner.
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Assist submission of product dossiers, as well as ensure proper electronic archiving of all documents submitted to and received from Competent Authorities and Notified Bodies, to accurate data timely and keep update regulatory databases and tools for assigned products to comply.
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Update and maintain product registration and ingredients archives, databases and tracking tools.
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Upload and maintain technical files/dossier databases, as well as upload and maintain as required any documentation supporting the placing of the market of other categories of products; e.g. cosmetics, home care, consumer goods
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Work closely with other regions to obtain the relevant documents and information for product dossiers.
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Collect appropriate documentation in order to support regulatory submissions in other countries when products are cross border sourced.

Artwork Approval:

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Assist the Regional Regulatory Affairs managers in the creation of ingredient list for labeling purposes
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Assist the RA managers with artwork review and approval

Regulatory intelligence and product advocacy activities:

Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).

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Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.

Requirements:

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Bachelor degree in Chemistry, Chemical Pharmaceutical, Engineer in Chemistry or any related area.
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Preferably 1-2 years of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar industries.
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Understanding of registration and regulatory requirements.
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Knowledge of industry practices, techniques and standards.
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Good written and verbal communicator with excellent interpersonal skills.
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Good planning and organizing skills.
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Ability to work under stress and meet deadlines.
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Knowledge of English and Portuguese language is advantageous.
Equal Opportunity Employer

Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition.

Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom's of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill's Science Diet and Hill's Prescription Diet.